Moderna Vaccine - Product Scorecard

Company: Moderna

Type: Covid-19 Vaccine
Product (brand name): mRNA-1273 (SpikeVax)
0%
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with criteria
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Explore the results of PAF’s research into the behaviour of Moderna . Each section is given an overall score; individual criteria are also scored (see icon following the criteria heading).

Click on ‘Explanation about the score’ sign next to each entry to expand and learn more.

Category A: Commitments and Accountability

The company should publicly commit to human rights in relation to product development and marketing, by adopting an official human rights policy statement recognising the right to the highest attainable standard of health. The company should endeavour to integrate human rights into its strategies, policies, programmes, projects, and activities.

The company should also have a publicly available global access plan for their Covid-19 product, based on human rights standards, with measurable targets and lines of accountability.

A1: Does Moderna publish a global access plan for its product?

Moderna has a five-pillar strategy to ensure that low-income countries get access to its vaccine, including: not enforcing patents, supporting the Covax facility, facilitating donations by countries that bought more doses than they need, building an mRNA facility in Africa, and delivering between 2 to 3 billion doses to low-income countries in 2022.

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A2: Does Moderna commit to comply with human rights standards in relation to product development and marketing?

Moderna has a human rights policy which does not mention compliance with UN Guiding Principles on Business and Human Rights.

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Category C: International cooperation

The company should constructively engage with international initiatives for the equitable distribution of vaccines and therapeutics, such as the Covid-19 Technology Access Pool (C-TAP) or the Medicines Patent Pool (MPP), and the ACT Accelerator (COVAX). The company should also publicly commit to not enforcing the exclusive rights of Covid-19 related patents, and enter into non-exclusive, transparent licensing agreements for its Covid-19 products with other companies.

C1: Does Moderna commit to C-TAP or MPP?

Moderna has not shown evidence of supporting a responsible licensing mechanism such as C-TAP or the MPP.

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C2: Does Moderna commit to not enforcing the exclusive rights of Covid-19 related patents?

In October 2020, Moderna vowed not to enforce its patent rights during the pandemic and that it would be willing to license them to others after the pandemic.

On 08 February 2022, Moderna updated this pledge, stating that it will “never enforce its patents for COVID-19 vaccines against manufacturers in or for the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment (AMC), provided that the manufactured vaccines are solely for use in the AMC 92 countries.” This is a narrower version of Moderna’s previous pledge,

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C3: Does Moderna supply to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator?

Moderna has donated 650 000 000 doses through COVAX.

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C4: Does Moderna agree to license its Covid-19 medical products to other companies?

Moderna has established multiple fill-and-finish and distribution sites: Cipla (India), Rovi Pharma (Nigeria), Thermo-fisher, Samsung Biologics.

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Category E: Equality, non-discrimination & equity

The company should engage in efforts to further equitable distribution of Covid-19 vaccines/therapeutics, by equitably distributing its supplies globally, devising fair pricing strategies, and making the active ingredient for its product available to other manufacturers. The company should also engage in full technology transfer to other manufacturers, including the necessary transfer of skills, legal components, knowledge and intellectual property. Where applicable, the company should agree to waive rights in regulatory test data, and refrain from enforcing TRIPS+ measures.

E1: Does Moderna make the active ingredient available on reasonable grounds? [Only for therapeutics]

[Only applies to therapeutics]

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E2: Does Moderna commit to full technology transfer to other manufacturers?

Moderna does not commit to full technology transfer to other manufacturers.

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E3: Does Moderna commit to non-profit, ‘fair’, or differential pricing?

Moderna states that it will make profit from the vaccine. There are different prices for the vaccine but those paid by middle-income countries and low-income countries are sometimes more than what is paid by high-income countries (Botswana, eg, payed 28,88 US dollars and the EU paid 25,50). The different prices cannot therefore be considered as part of a differential pricing policy based on ability to pay.

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E4: Does Moderna equitably distribute supplies globally? [Only applies to vaccines]

Moderna has sold only 31.5% of its doses to low- and middle-income countries.

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E5: Does Moderna not seek protection beyond the minimum criteria in TRIPS, or not enforce TRIPS+ measures? [where applicable]

No information was found on this criterion.

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E6: Does Moderna agree to waive exclusive rights in regulatory test data? [where applicable]

No information was found on this criterion.

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Category T: Transparency

The company should be as transparent as possible, by publishing its research and development costs, profit margin, average costs of production, and production capacity for its Covid-19 product. It should also disclose the amount of public subsidies received during product development and/or testing. Licensing agreements should also be made publicly available and clinical trials should be registered in public repositories.

T1: Does Moderna publish its R&D costs?

Moderna published its research and development (R&D) costs for each quarter of 2021 and attributes the increase in 2nd and 3rd quarter report to increased headcount and R&D costs for COVID vaccine: “Research and development expenses were $521 million for the three months ended September 30, 2021, compared to $344 million for the same period in 2020. Research and development expenses were $1.3 billion for the nine months ended September 30, 2021, compared to $611 million for the same period in 2020. The growth in spending in 2021 was mainly due to increases in clinical trial expenses and personnel-related costs, largely driven by increased mRNA-1273 clinical development and headcount.”

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T2: Does Moderna publish its profit margin?

Moderna states in its 2021 financial report: “Product sales for the three and nine months ended September 30, 2021 were $4.8 billion and $10.7 billion, respectively, from sales of 208 million and 510 million doses of the Company’s COVID-19 vaccine for the three and nine months ended September 30, 2021, respectively”, but does not mention a margin.

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T3: Does Moderna publish the average and/or marginal costs of production?

The average and/or marginal costs of producing the vaccine are not published.

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T4: Does Moderna publish its production capacity?

Moderna plans to produce between 2 and 3 billion doses in 2022.

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T5: Does Moderna publish the public subsidies it received during product development and/or testing?

Moderna publishes the funding amount received from US BARDA: “The increase in grant revenue of $286 million for the nine months ended September 30, 2021 was primarily driven by an increase in revenue from BARDA related to the Company’s COVID-19 vaccine development. Grant revenue for the three months ended September 30, 2021 was relatively flat compared to the same period in 2020.”

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T6: Does Moderna publish the text of licensing agreements?

Moderna has not published the texts of any licensing agreements.

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T7: Does Moderna register its clinical trials in public repositories?

Moderna has registered its clinical trials on clinicaltrials.gov.

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